Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment
|ClinicalTrials.gov Identifier: NCT00827047|
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : April 1, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Procedure: Total hemihepatic vascular exclusion Procedure: Hemihepatic vascular Clamping Procedure: Pringle's Maneuver||Not Applicable|
The amount of blood loss and blood transfusion in Hepatectomy have a detrimental effect on the prognosis for Hepatocellular carcinoma(HCC).Intraoperative bleeding remains a major concern during liver resection. The most often used hepatic vascular control methods at present are hepatic pedicle occlusion(Pringle maneuver), hemihepatic vascular clamping,segmental vascular clamping and total hepatic vascular exclusion (THVE).However,all these methods have shortcomings. Pringle maneuver cannot prevent bleeding from hepatic veins and leads to ischemia-reperfusion injury of the liver; Hemihepatic vascular clamping cannot prevent bleeding from hepatic veins as well, and from the remnant (nonoccluded) liver. THVE is a technically demanding technique that requires surgical and anesthetic expertise and may lead to hemodynamic intolerance as well as increased morbidity and hospital stay. Total hemihepatic vascular exclusion(THHVE),completely isolates the right or left hemiliver ipsilateral to the lesion that requires resection from the systemic circulation,has the advantage of preventing backflow hemorrhage or air embolism without having to resort to caval blood flow interruption of THVE.
The purpose of this study is to evaluate if THHVE can raduce bleeding,reduce the incidence of complications and improve the patient's free survival and overall survival compared with other occlusion methods.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Controlled Trial of Total Hemihepatic Vascular Exclusion in Hepatectomy in Hepatocellular Carcinoma Treatment|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2012|
Active Comparator: Total Hemihepatic Vascular Exclusion
Patients with HCC received Total Hemihepatic Vascular Exclusion in hepatectomy.
Procedure: Total hemihepatic vascular exclusion
A long vascular clamp is inserted along the midline of the anterior surface of the vena cava,proceed cranially up to the space between the right and the middle hepatic vein trunks. Two tapes are seized with the clamp passing between the anterior surface of the IVC and the liver parenchyma.One tape is use to pass around the hepatic parenchyma for occlusion of the bleeding from the remnant liver;the other is used to loop the right (or left )hepatic vein trunk and short hepatic vein,as well as inferior right hepatic vein,if present. Selectively interrupts the arterial and portal inflow to the part of the liver (right or left hemiliver)ipsilateral to the lesion that requires resection.Thus total hemihepatic vascular exclusion is achieved.
Other Name: THHVE group
Experimental: Hemihepatic vascular Clamping
Patients with HCC received Hemihepatic vascular Clamping in hepatectomy.
Procedure: Hemihepatic vascular Clamping
Selectively interrupts the arterial and portal inflow to the part of the liver (right or left hemiliver)ipsilateral to the lesion that requires resection. Selective clamping can be achieved after carefully dissecting the right from the left hilar branches or after inserting a clamp between the right and left hilar branches without prior hilar dissection and looping the right or left portal structures with a tape.
Other Name: Hemihepatic vascular Clamping group
Experimental: Pringle's Maneuver
Patients with HCC received Pringle's Maneuver in hepatectomy.
Procedure: Pringle's Maneuver
Hepatic pedicle clamping is performed by encircling the hepatoduodenal ligament with a tape and then applying a tourniquet or a vascular clamp until the pulse in the hepatic artery disappears distally.
Other Name: Pringle's Maneuver group
- Overall survival and disease free survival [ Time Frame: 1,2,or 3 years ]
- Bleeding and blood transfusion ,hepatic function of patients after surgery, the incidence rate of complications [ Time Frame: 1,2,or 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00827047
|Eastern hepatobilliary surgery hospital|
|Shanghai, Shanghai, China|
|Study Chair:||Feng Shen, M.D||Eastern Hepatobiliary Surgery Hospital, Second Military Medical University|